Long-term Special Drug Use Investigation of Molidustat for Patients With Renal Anemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,081
- 试验地点
- 1
- 主要终点
- Incidence of safety events
研究概览
简要总结
In this study, the researchers want to learn more about the safety and effectiveness of Molidustat in Japanese men and women who have renal anemia, a condition in which the kidneys do not make enough of a hormone that helps the body make new red blood cells.
In previous clinical trials with a small number of participants, several important adverse events were observed. The researchers in this study want to know how many patients also have these adverse events under the real world, and if the number of the red blood cells will be increased after the treatment of Molidustat.
The researchers will collect the participants' health information from their medical records and their regular check-ups for up to 2 years. The data from this study will be submitted to the health authority in Japan in accordance with the local regulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male participants with a diagnosis of renal anemia
- •Decision to initiate treatment with Molidustat was made as per investigator's routine treatment practice
- •Molidustat naïve participants (with including the participants treated within three months before the contracted date at each site)
- •Signed informed consent
排除标准
- •- Contra-indications according to the local marketing authorization
研究组 & 干预措施
Molidustat
Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators
干预措施: Molidustat (Musredo, BAY85-3934) (Drug)
结局指标
主要结局
Incidence of safety events
时间窗: Up to approximately 24 months
Adverse Events/Adverse Drug Reactions including thromboembolism, hypertension, malignant tumor retinal hemorrhage, Major Adverse Cardiovascular Events (MACE) without thromboembolism, Interstitial lung disease (ILD) and Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) in renal anemia patients
次要结局
- Absolute changes of Hemoglobin (Hb) levels from the baseline(Up to approximately 24 months)
- Incidence of safety events in dialysis and non-dialysis participants(Up to approximately 24 months)
- Percentage changes of Hb levels from baseline in sub-group analysis(Up to approximately 24 months)
- Time course of Hb levels from the baseline(Up to approximately 24 months)
- Incidence of safety events (important identified risk and important potential risk) by patient background(Up to approximately 24 months)
- Percentage changes of Hemoglobin (Hb) levels from the baseline(Up to approximately 24 months)
- Absolute changes of Hb levels from baseline in sub-group analysis(Up to approximately 24 months)
- Proportion of participants with Hb level within target range(Up to approximately 24 months)